This study will examine the recombinant, that is, produced by genetic engineering, protective
antigen (rPA) that brings about antibodies to neutralize the anthrax toxin and that could
therefore be predicted to offer protection against anthrax. Today, anthrax is rarely
encountered in the United States, since the introduction of vaccines for cattle in the 1930s.
A human vaccine was licensed in 1970. Vaccination against anthrax has been confined to people
at risk, such as wool sorters and some veterinarians. However, the rising prospects of B.
anthracis being used as a weapon have led to routine administration of the anthrax vaccine to
members of the armed forces.
Adults who are in good health may be eligible for this study. The involvement of 300 adults
is planned.
Participants will have a general physical exam and test for vital signs. There will also be
collection of blood for chemistry and hematology; urinalysis; tests for HIV, hepatitis B and
C, and liver function; and a pregnancy test, if applicable.
On a random basis, patients will receive one of the rPA formulations. Two doses of rPA will
be evaluated, 10 microgram ((Micro)g) and 20 (Micro)g. This evaluation aims to establish the
safety and most desirable level of dosage. Patients will receive one injection of the
vaccine, administered in the left shoulder or left thigh. About 30 minutes later, their
temperature will be taken, and the injection site will be inspected. Rare but severe
reactions could occur if there is extreme sensitivity to a vaccine. However, such an
occurrence is extremely rare following a vaccine, and if there are any dangerous symptoms,
they can be effectively treated by medications available to patients while they are at the
clinic. If there are no significant abnormal results, patients may return home. About 6 hours
later and daily for 7 days, they will take their temperature and examine the injection site.
The vaccine may cause temporary discomfort at the site of injection, and participants may
experience a mild fever for 1 or 2 days after vaccination.
Patients will receive diary cards, a digital thermometer, and instructions on taking their
temperature and measuring redness and swelling at the injection site, as well as for
recording aches, muscle pain, or sensitivity to light for 7 days. They will be examined at
the clinic at 72 hours following vaccination and also on the 7th day if they have a fever at
or above 100.4 , if swelling is at or more than 2 inches, or if they request an exam.
Meanwhile, a clinic staff member will call patients and discuss the findings. Then patients
will receive a second and third injection of the same vaccine at 2-month intervals. There
will also be interviews about patients' health at each visit to the clinic, plus monitoring
of the vaccination after 6 hours and for 7 days. One year later, patients will receive a
fourth injection of the same vaccine.
Direct benefit to participants in this study is not guaranteed, although an antibody response
is predicted. The results in this study will help in the development of improved vaccines for
anthrax.
Phase:
Phase 1
Details
Lead Sponsor:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)